Calidad y conformidad

(sólo en alemán, francés e inglés)

In the field of medical technology products, quality regulations are particularly strict. This applies to all processes, including the means of production used and their environment. Cendres+Métaux has in-depth knowledge of the  applicable regulations. Our processing systems and equipment have all the necessary qualifications, including cleaning technology for cleanliness from level 1 (free from operating residues) up to level 4 (with microbiological requirements) and for clean rooms (ISO class 7). We are regularly certified (MDD 93/42/EEC, ISO 13485 / 14001 / 9001) as well as registered as a subcontractor with the FDA and jPAL. Furthermore, additional customer-specific procedures can also be agreed and integrated.

  • Certified according to MDD 93/42/EEC, ISO 13485 / 14001 / 9001
  • FDA-registered supplier according to 21CFR820
  • Registered certification according to jPAL
  • Accredited as a testing laboratory according to ISO/IEC 17025
  • Qualification & auditing of suppliers
  • Traceability across products, materials used and processes
  • Testing and process integration:
    • Process development & validation (IQ, OQ, PQ)
    • First Article Inspection (FAI)
    • Statistical Process Control (SPC)
    • Management of sterilisation validation
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